Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Randox Calibration Serum Level 3 (Catalog Number: CAL2351)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Randox Calibration Serum Level 3 (Catalog Number: CAL2351) see related information
Date Initiated by Firm July 12, 2019
Create Date September 07, 2019
Recall Status1 Terminated 3 on June 17, 2020
Recall Number Z-2490-2019
Recall Event ID 83373
510(K)Number K053153  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Code Information Lot Numbers: 961UE onwards GTN: 05055273200966
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories Ltd. issued Urgent Medical Device Correction letter on 7/12/19 advising users of the problem, health risk and action to take: Replace all Quality Control value sheets with the revised sheets available on www.randox.com . Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
Quantity in Commerce 307 kits
Distribution Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = RANDOX LABORATORIES, LTD.
-
-